Events

Recall of ADVIA Chemistry Systems A1c_3 Calibrators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68871
  • Event Risk Class
    Class 2
  • Event Number
    Z-2643-2014
  • Event Initiated Date
    2014-08-06
  • Event Date Posted
    2014-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128896
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calibrator, multi-analyte mixture - Product Code JIX
  • Reason
    The advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. depending on quality control limits, this issue may not have been detected. note: the percent bias range is a percentage of the hba1c result. it is not absolute hba1c units.
  • Action
    Siemens sent an Urgent Field Safety Notice dated August 2014 to all affected consignees on August 6, 2014 via Federal Express. The letter instructed consignees to discontinue use and discard calibrator lots 3HD044 and 3LD068. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Distribution of the Urgent Field Safety Notices to foreign consignees was determined at the country level. For questions regarding this recall call 914-524-2955.

Device

ADVIA Chemistry Systems A1c_3 Calibrators
  • Model / Serial
    Lots 3HD044 (exp. 11/01/2015), and 3LD068 (exp. 01/01/2016)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Austria, Brazil, Canada, China, Colombia, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Istanbul, Italy, Lithuania, Mexico, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Uruguay, Vietnam, and Zambia.
  • Product Description
    ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD || ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. || The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA